Spinal Cord Stimulation (SCS)-The Implantable Systems Performance Registry (ISPR)

Area of Science:

• Biomedical Engineering
• Clinical Research
• Medical Device Technology

Background:

• The Implantable Systems Performance Registry (ISPR) was established to track the real-world performance of Medtronic's Spinal Cord Stimulation (SCS) and intrathecal drug infusion systems.
• Monitoring device performance is crucial for ensuring patient safety and guiding future product improvements.

Purpose of the Study:

• To evaluate the product performance and safety of Medtronic SCS and intrathecal drug infusion systems in the United States.
• To collect and analyze real-world data on implantable device performance over time.

Main Methods:

• Data were collected from 2605 patients across 44 centers in the US between 2004 and 2014.
• Actuarial life table methods were employed to estimate device survival rates.
• Patient demographics and follow-up durations were recorded, with an average follow-up of 20.1 months.

Main Results:

• Neurostimulator survival rates exceeded 97% for all models.
• Extension models demonstrated over 95% survival from extension-related events.
• Lead-related events were the most frequent performance issues, with most lead families showing over 75% survival at 5 years.

Conclusions:

• The ISPR provides valuable real-world safety and performance data for implantable systems.
• ISPR findings are instrumental in directing future product development to enhance reliability and quality.